UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052025 |
|---|---|
| Receipt number | R000059384 |
| Scientific Title | Wearing study of 1-day contact lenses |
| Date of disclosure of the study information | 2023/09/04 |
| Last modified on | 2023/11/29 12:02:58 |
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Basic information
Public title
Wearing study of 1-day contact lenses
Acronym
Wearing study of 1-day contact lenses
Scientific Title
Wearing study of 1-day contact lenses
Scientific Title:Acronym
Wearing study of 1-day contact lenses
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the wearing comfort of HOYA 1-day contact lenses BC8.8mm in Japanese people who are currently wearing daily disposable contact lenses.
Basic objectives2
Others
Basic objectives -Others
Wear comfort
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of wearing comfort of the test lens
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing HOYA 1-day contact lenses BC8.8mmA and 8.8mmB for each 7 days.
Interventions/Control_2
Wearing HOYA 1-day contact lenses BC8.8mmA and 8.8mmB for each 7 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Be aged 18 years or more.
2)Wearing spherical daily disposable soft contact lenses in both eyes for at least 3 months and 5 days a week
3)Contact lens sphere requirement between -1.00 to -9.00 D
4)Be correctable by sphero-cylindrical refraction to 1.0 decimal or better in each eye.
5)Be able to answer questionnaires and be able to visit the hospital on the designated day.
6)After being fully informed about participation in this research, sufficient understanding is obtained, and the patient's voluntary written consent is obtained.
Key exclusion criteria
1)Corresponding to the contraindications/prohibitions described in the IFU of the test lens
2)Have a disease or any systemic illness that the investigator considers may interfere with contact lens wear
3)Eye disease other than refractive error
4)Investigator or subject determines that the fit or visual acuity with the study lens is unacceptable.
5)Investigator judged that it was inappropriate as a research subject.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motozumi |
| Middle name | |
| Last name | Itoi |
Organization
Dogenzaka Itoi Eye Clinic
Division name
Ophthalmology
Zip code
150-0043
Address
1-10-19 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-5784-4616
kobayashi@c-ctd.co.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Kobayashi |
Organization
CTD inc.
Division name
Pharmaceutical Promotion Department
Zip code
1040042
Address
1-2-9, Irifune, Chuo-ku, Tokyo
TEL
03-6228-4835
Homepage URL
kobayashi@c-ctd.co.jp
Sponsor or person
Institute
Dogenzaka Itoi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
HOYA Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research Ethical Review Board
Address
1-13-23, Ikebukuro Toshima-ku, Tokyo
Tel
03-6868-7022
cts-clinicalmanegement-all@3hcts.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059384
